Events

Recall of Anspach MCA Cutting Burr, DFU Rx Only

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by The Anspach Effort, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67177
  • Event Risk Class
    Class 2
  • Event Number
    Z-0715-2014
  • Event Initiated Date
    2012-03-29
  • Event Date Posted
    2014-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124873
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Drills, Burrs, Trephines & Accessories (Simple, Powered) - Product Code HBE
  • Reason
    Current directions for use for the mca cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the mca burrs.
  • Action
    Anspach sent an Urgent Medical Device Labeling Correction letter dated Marach 29,, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the item 18-0079 with their inventory immediately, complete the attached reply form indicating their receipt of the letter. Return the completed form by fax to the number or email provided on the form. If product was further distributed to other facilities, the correction letter should be forwarded to them. Customers with quesitons should call 1-800-327-6887 or email customer.support@synthes.com or ProductSupportTeam@Synthes.com. For questions regarding this recall call 561-627-1020.

Device

Anspach MCA Cutting Burr, DFU Rx Only
  • Model / Serial
    ALL LOTS for product code 18-0001
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and Netherlands.
  • Product Description
    Anspach MCA Cutting Burr, DFU Rx Only || Designed for cutting and shaping delicate bone, primarily in otology procedures
  • Manufacturer
    The Anspach Effort, Inc.

Manufacturer

The Anspach Effort, Inc.
  • Manufacturer Address
    The Anspach Effort, Inc., 4500 Riverside Drive, Palm Beach Gardens FL 33410-4235
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA